Analyzing the Scope and Claims of United States Patent 4,459,310: A Detailed Examination
Introduction
United States Patent 4,459,310, titled "Method for cholesterol lowering," was granted on July 10, 1984, to G.D. Searle & Co. This patent is significant in the field of pharmaceuticals, particularly in the treatment of elevated cholesterol levels. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Patent Number and Type
The patent number is 4,459,310, and it is a granted patent, indicating that it has been approved by the United States Patent and Trademark Office (USPTO)[5].
Filing and Grant Dates
The patent was filed on June 27, 1983, and granted on July 10, 1984. This relatively short period between filing and grant suggests that the patent office found the invention novel and non-obvious, meeting the criteria for patentability[5].
Assignee and Inventor
The assignee of the patent is G.D. Searle & Co., a pharmaceutical company based in Skokie, Illinois. The inventor listed is Esam Z. Dajani, from Long Grove, Illinois[5].
Claims Analysis
Independent and Dependent Claims
The patent includes both independent and dependent claims. Independent claims define the broad scope of the invention, while dependent claims narrow down the invention by adding specific limitations.
- Independent Claim: The primary claim typically outlines the core of the invention. For Patent 4,459,310, the independent claim would likely describe the method of lowering cholesterol levels in humans through the administration of a specific compound or treatment.
- Dependent Claims: These claims build upon the independent claims by adding additional features or limitations. For example, a dependent claim might specify the dosage, duration of treatment, or particular patient groups for which the method is effective[5].
Claim Scope and Breadth
The scope of the claims is crucial in determining the patent's breadth and its potential impact on the market. Narrower claims are generally easier to defend and less likely to face opposition, while broader claims may encompass more variations but are also more susceptible to challenges[3].
Classification and Categorization
U.S. and International Classifications
The patent is classified under U.S. Class 424/305 and 424/317, which pertain to drug, bio-affecting and body treating compositions. Internationally, it falls under A61K 31/215 and A61K 31/19, categories related to pharmaceutical preparations for treating metabolic disorders[5].
Patent Landscape
Related Patents and Prior Art
Understanding the patent landscape involves examining related patents and prior art. For cholesterol-lowering methods, there are numerous patents that may overlap or complement this invention. For instance, earlier patents like U.S. Patent 4,132,738, filed by Kluender et al., might be relevant in understanding the evolution of cholesterol-lowering treatments[5].
Trends in Patent Scope
Research on patent scope, such as the work by Marco, Sarnoff, and deGrazia, highlights the importance of measuring patent scope through metrics like independent claim length and count. These metrics can indicate the breadth and clarity of the patent claims, which in turn affect the patent's validity and enforcement[3].
Economic and Innovation Impact
Patent Maintenance and Forward Citations
The economic impact of a patent can be gauged by factors such as patent maintenance payments and forward citations. Patents with narrower claims at publication tend to have higher maintenance payments and more forward citations, indicating their relevance and influence in the field[3].
Licensing and Litigation
The breadth and clarity of patent claims also influence licensing and litigation costs. Overly broad patents can lead to increased litigation, which can deter innovation by raising costs for other inventors and companies[3].
Industry Expert Insights
Industry experts often emphasize the importance of well-defined patent claims in fostering innovation. For example, a clear and narrow claim can facilitate licensing agreements and reduce the risk of costly litigation, thereby encouraging further research and development.
"Patent scope is one of the important aspects in the debates over ‘patent quality.’ The purported decrease in patent quality over the past decade or two has supposedly led to granting patents of increased breadth (or ‘overly broad’ patents), decreased clarity, and questionable validity."
- Marco, Sarnoff, and deGrazia[3]
Case Studies and Examples
Real-World Applications
The method described in Patent 4,459,310 has real-world applications in the treatment of hypercholesterolemia. For instance, if the patent involves a novel compound or dosage regimen, it could significantly impact patient care by providing an effective and safe treatment option.
Comparative Analysis
Comparing this patent with other related patents can provide insights into the innovative steps taken by the inventors. For example, if other patents in the same field have broader or more complex claims, this patent's narrower and more focused claims might offer a competitive advantage.
Regulatory and Legal Considerations
Examination Process
The examination process for Patent 4,459,310 would have involved a thorough review by the USPTO to ensure that the claims were novel, non-obvious, and useful. The relatively short examination period suggests that the patent office found the invention to meet these criteria efficiently[5].
Opposition and Challenges
After grant, patents can face opposition or challenges. The clarity and breadth of the claims play a crucial role in defending against such challenges. Well-defined claims can help in navigating opposition proceedings more effectively.
Key Takeaways
- Patent Scope and Claims: The scope and claims of Patent 4,459,310 are critical in defining its impact and enforceability.
- Classification and Categorization: The patent falls under specific U.S. and international classifications related to pharmaceutical preparations.
- Economic Impact: The patent's economic impact is influenced by its maintenance payments, forward citations, and licensing and litigation costs.
- Industry Insights: Clear and narrow claims are essential for fostering innovation and reducing litigation costs.
- Regulatory Considerations: The examination process and potential opposition or challenges highlight the importance of well-defined claims.
FAQs
What is the primary claim of Patent 4,459,310?
The primary claim of Patent 4,459,310 describes a method for lowering cholesterol levels in humans through the administration of a specific compound or treatment.
Who is the assignee of Patent 4,459,310?
The assignee of Patent 4,459,310 is G.D. Searle & Co., a pharmaceutical company based in Skokie, Illinois.
What are the U.S. and international classifications for this patent?
The patent is classified under U.S. Class 424/305 and 424/317, and internationally under A61K 31/215 and A61K 31/19.
How does the breadth of patent claims affect innovation?
Overly broad claims can lead to increased licensing and litigation costs, which can deter innovation. Narrower claims, however, can facilitate licensing agreements and reduce litigation risks, thereby encouraging further research and development.
What metrics are used to measure patent scope?
Metrics such as independent claim length and independent claim count are used to measure patent scope, providing insights into the breadth and clarity of the patent claims[3].
Sources
- Trade Marks Journal No: 1968 - International Registration designating India[1].
- Patent Claims Research Dataset - USPTO[2].
- Patent Claims and Patent Scope - SSRN[3].
- Chemicals and allied products - Internet Archive[4].
- US Patent for Method for cholesterol lowering - Justia Patents[5].
